Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-28 @ 5:31 AM
Study NCT ID:
NCT05553561
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2022-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intense Regulated Pulse Light Therapy in Dry Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2022-09-07', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-invasive tear film break up time', 'timeFrame': 'before treatment', 'description': 'assessment of tear film through MediWorks device attached to the slitlamp'}, {'measure': 'Change in Non-invasive tear film break up time', 'timeFrame': 'Within 1 month after completion of treatment', 'description': 'assessment of tear film through MediWorks device attached to the slitlamp'}, {'measure': 'Tear Meniscus Height', 'timeFrame': 'before treatment', 'description': 'assessment of tear film through MediWorks device attached to the slitlamp'}, {'measure': 'Change in Tear Meniscus Height', 'timeFrame': 'Within 1 month after completion of treatment', 'description': 'assessment of tear film through MediWorks device attached to the slitlamp'}, {'measure': 'Lipid layer thickness', 'timeFrame': 'before treatment', 'description': 'assessment of tear film through MediWorks device attached to the slitlamp'}, {'measure': 'Change in Lipid layer thickness', 'timeFrame': 'Within 1 month after completion of treatment', 'description': 'assessment of tear film through MediWorks device attached to the slitlamp'}, {'measure': 'Meibomian glands % loss grading', 'timeFrame': 'before treatment', 'description': 'assessment of tear film through MediWorks device attached to the slitlamp'}, {'measure': 'Change in Meibomian glands % loss grading', 'timeFrame': 'Within 1 month after completion of treatment', 'description': 'assessment of tear film through MediWorks device attached to the slitlamp'}, {'measure': "patient's quality of life affection", 'timeFrame': 'before treatment', 'description': "The effect of dry eye on the patient's Quality Of Life was evaluated with the aid of Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire."}, {'measure': "Change in patient's quality of life affection", 'timeFrame': 'Within 1 month after completion of treatment', 'description': "The effect of dry eye on the patient's Quality Of Life was evaluated with the aid of Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IPL therapy', 'IRPL therapy', 'Dry eye', 'MGD'], 'conditions': ['Dry Eye Disease']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.', 'detailedDescription': 'Dry eye disease is a common ocular condition that needs prompt diagnosis and careful treatment interventions. If left untreated, it can lead to numerous sight threatening complications, including ulceration of the cornea, blepharitis, alterations of the tear film, conjunctivitis, and in severe cases, significant drying of the eye may lead to scarring, thinning, and even perforation of the cornea.\n\nIntense pulsed light (IPL) therapy is a new treatment strategy for treatment of MGD by inducing the restoration of the normal activity of the meibomian glands. In fact, IPL has been used for treating the patients with facial telangiectasias and erythema of rosacea and also resulted in improvement in ocular surface health.\n\nEvaporative form is the commonest form of DED and it is mainly caused by meibomian glands dysfunction (MGD). The usual traditional treatment options for MGD include warm compresses, expression of meibomian glands (MG), anti-inflammatory drugs, and lubricant eye drops.\n\nThe aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.\n\nThe study included 34 patients with moderate to severe evaporative dry eye. The symptoms will be assessed with the Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire. The tear film will be assessed through MediWorks D130+S390L (WDR) which is a device attached to the slit lamp for non-invasive examination of tear film.\n\nPatients will be divided into 2 groups: The 1st group include (17) patients who will be treated with Intense Regulated Pulse Light (IRPL) \\& the 2nd group include (17) patients will treated by traditional methods of MGD as Eyelid hygiene, topical lubricant, topical \\& systemic antibiotics \\& anti-inflammatory agents\n\nIRPL will be done using E-Eye (E-Swin, France) \\& each patient will undergo 3 sessions on Day (1), Day (15), and Day (45).\n\nThe patients will be reassessed after the 3rd session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with moderate to severe dry eye disease \\& clinicaily significant signs of meibomian gland dysfunction\n\nExclusion Criteria:\n\n* Use systemic medications known to affect the eye two weeks prior to baseline assessment.\n* Pregnancy.\n* Ocular surgery or dermatologic treatments in the previous Two months or during the treatment period.\n* Implants, tattoos, or pigmented lesions in the treatment area.\n* Contraindications to IPL therapy, including the use of photosensitive medications.'}, 'identificationModule': {'nctId': 'NCT05553561', 'briefTitle': 'Intense Regulated Pulse Light Therapy in Dry Eye Disease', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Therapeutic Effect of Intense Regulated Pulse Light in Patients With Dry Eye Disease', 'orgStudyIdInfo': {'id': '7/2022OPHT23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IRPL Therapy', 'description': '17 patients with moderate to severe evaporative dry eye disease will treated with 3 sessions of IRPL therapy.', 'interventionNames': ['Procedure: IPRL device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non IRPL Therapy', 'description': '17 patients with moderate to severe evaporative dry eye disease will treated with traditional methods of MGD', 'interventionNames': ['Procedure: pharmacological therapy & Eyelid hygiene']}], 'interventions': [{'name': 'IPRL device', 'type': 'PROCEDURE', 'description': 'Intense pulsed light therapy (IPL) is a non-coherent large wavelength high-intensity light in the range of 500-1200nm. It has been used by many investigators for the treatment of evaporative dry eye safely and effectively.', 'armGroupLabels': ['IRPL Therapy']}, {'name': 'pharmacological therapy & Eyelid hygiene', 'type': 'PROCEDURE', 'description': 'traditional methods of MGD treatment as Eyelid hygiene, topical preservative free lubricant, topical \\& systemic antibiotics \\& anti-inflammatory agent', 'armGroupLabels': ['Non IRPL Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Menoufia', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Monoufia university'}], 'centralContacts': [{'name': 'Rofaida Mostafa Mansour, Master degree in ophthalmology', 'role': 'CONTACT', 'email': 'drrofaidamostafa1989@gmail.com', 'phone': '01000502442'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmologist at Menoufia university hospitals', 'investigatorFullName': 'Rofaida Mostafa Mansour Serag EL Deen', 'investigatorAffiliation': 'Menoufia University'}}}}